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To replace damaged female luer connectors, clamps, or repair extensions where there is a minimum of 2.5 cm viable extension tubing. Repairs Spire BioMedical Xpresso®, Decathlon™, & Alta LR™ catheters.

The Spire BioMedical repair kit is used to replace damaged female luer connectors, clamps, or repair extensions where there is a minimum of 2.5 cm viable extension tubing. This repair kit is to be used on the Spire BioMedical Xpresso®, Decathlon™, and Alta LR™ catheters.

The provided K062435 document describes a 510(k) premarket notification for a "Repair Kit for XpressO®, Decathion™, and Alta LR™ Catheters." This device is a repair kit for existing medical catheters, and the submission focuses on demonstrating substantial equivalence to a predicate device, the Pourchez Retro Repair Kit (K022644).

Given the nature of this submission (a repair kit for existing catheters, demonstrating equivalence to an existing repair kit), the "study" conducted is a series of bench tests rather than a clinical trial involving human or animal subjects that falls under a typical AI/ML performance study. The focus is on physical and material characteristics.

Therefore, many of the requested categories (such as sample size for test/training sets, ground truth establishment for AI, expert involvement, MRMC studies, standalone AI performance) are not applicable to this type of device and submission. The "acceptance criteria" and "device performance" in this context refer to the physical and mechanical properties tested during bench validation.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "A series of physical tests were conducted to demonstrate substantial equivalence to the Pourchez Retro Repair Kit (K022644). Refer to Section 18 'Bench Testing' for physical test data."

However, Section 18 "Bench Testing" is not included in the provided excerpts. Therefore, the specific acceptance criteria and the quantitative reported performance values are not available here. We can infer that the general acceptance criterion would be that the repair kit's performance in these physical tests is equivalent to or not worse than the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified in the provided document. For physical bench testing, sample sizes vary depending on the specific test and statistical requirements.
• Data Provenance: The tests were conducted "in-house" by Spire Biomedical, Inc. (manufacturer), likely at their facility in Bedford, MA, USA. This is a retrospective evaluation based on laboratory testing of the device prototypes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable. For physical bench testing of a medical device repair kit, "ground truth" is typically established by engineering specifications, material standards, and benchmark performance of predicate devices, not by expert consensus on clinical data. The tests are objective measurements of physical properties.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1 or 3+1) are relevant for subjective assessments, such as image interpretation or clinical outcomes, typically involving multiple human readers. Bench testing involves objective measurements against established technical specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• Not Applicable. This device is not an AI/ML-driven diagnostic or assistive tool for human readers. It's a physical medical device repair kit.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done

• Not Applicable. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

• For physical tests: Engineering specifications, material standards, and benchmark performance data of the predicate device (Pourchez Retro Repair Kit K022644).
• For biocompatibility: Adherence to recognized biocompatibility standards (e.g., ISO 10993 series) for medical devices.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no "training set." The repair kit itself is the "device," designed and manufactured according to specifications.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set for an AI/ML model, this question does not apply.

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Spire Biomedical Inc.'s RetrO Silver™ and XpressO Silver™ Coated Twin Lumen Chronic Hemodialysis Catheters with Separated Tips are designed for chronic hemodialysis and apheresis. They are radiopaque silicone catheters designed for percutaneous insertion or insertion via a cutdown. Catheters longer than 40cm are intended for femoral vein insertion. The silver coating on the catheter may reduce bacterial surface colonization for up to two months. This performance was supported by literature citing clinical testing.

Spire Biomedical, Inc.'s RetrO Silver™ and XpressO Silver™ are radiopaque silicone catheters that have been coated with silver using a physical vapor deposition process. The silver is applied to the distal end of the catheter from approximately 2-5mm below the cuff to the tips, and is on the exterior surfaces of the catheter only. Aside from the silver coating, the catheters have identical physical characteristics to the non-coated RetrO and XpressO catheters, both of which have 510(k) Premarket Approval. The catheter configurations (available lengths and insertion kit components) are also identical. The silver coating is applied by a vacuum-based physical vapor deposition process called ion beam assisted deposition (IBAD). IBAD combines evaporation with concurrent ion beam bombardment. The process is performed under a high vacuum environment. A silver vapor is formed via electron beam evaporation and deposited onto the catheter. Simultaneously, energetic ions bombard the catheter surface and coating as it is deposited. The coating consists of three layers: titanium, palladium, and silver. The film layers are deposited sequentially with the titanium and palladium layers being completely covered by the silver.

This document, K060288, describes the Spire Biomedical, Inc.'s RetrO Silver™ and XpressO Silver™ Coated Twin Lumen Chronic Hemodialysis Catheters with Separated Tips. The key performance claim for these devices is the silver coating's ability to reduce bacterial surface colonization for up to two months.

Here's an analysis of the acceptance criteria and the study that supports it:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

For the reduction of bacterial surface colonization, the document refers to a published clinical study by Bambauer et al. (2001). The sample size and specific details of the test set for this study are not provided in the submission itself, but would be found in the referenced publication. The data provenance is implied to be clinical, but the country of origin is not specified in this document. It is a retrospective reference to existing literature.

For frictional resistance, silver coated catheters and uncoated catheters were compared. The document doesn't specify the exact number of catheters in the test set, but states "Tests were conducted at several different normal load conditions" and "All measurements were conducted in the dry state." This was a prospective in-vitro bench test.

For silver elution rates, "segments were cut from the shafts of silver coated catheters" and "Tests were performed in triplicate for periods ranging from 1 day to 8 weeks." This was a prospective in-vitro bench test with a sample size of at least three per time point.

For equivalent flows and mechanical properties, these were compared to predicate devices. The document does not specify the sample size but implies an in-vitro equivalence study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

For the reduction of bacterial surface colonization, the information is based on a referenced clinical study. The number and qualifications of experts involved in establishing the ground truth (e.g., diagnosing infections, culturing bacteria) for that study are not provided in this 510(k) submission.

For the in-vitro tests (frictional resistance, silver elution rates, flows, mechanical properties), "experts" in the traditional sense of medical diagnoses were not involved. The ground truth was established through laboratory measurement protocols and analyses by qualified technical personnel within Spire Biomedical or a contract lab.

4. Adjudication Method for the Test Set

Given the nature of the evidence provided (reference to a clinical study for bacterial colonization, and in-vitro bench testing for other characteristics), there is no mention of an adjudication method (like 2+1 or 3+1 consensus) in this submission. This type of adjudication is typically relevant for studies involving human interpretation of medical images or symptoms, which is not the primary focus of the performance data presented here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or reported in this submission. The device is a physical medical device (catheter), and its performance data focuses on material properties, bacterial colonization rates, and mechanical equivalence, rather than human interpretation or diagnostic aid. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" does not apply.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

This question is not applicable to this device. The RetrO Silver™ and XpressO Silver™ catheters are physical medical devices, not AI algorithms. Their performance is described in a standalone manner, entirely independent of human-in-the-loop performance in the context of interpretation or decision-making.

7. Type of Ground Truth Used

• Reduction of Bacterial Surface Colonization: The ground truth for this claim is based on clinical testing from referenced literature. This would typically involve microbiological culture results or clinical infection rates.
• Frictional Resistance: The ground truth was established through direct physical measurement using a test rig platform.
• Silver Elution Rates: The ground truth was established through chemical analysis (measuring silver concentration in solution) in laboratory immersion studies.
• Equivalent Flows and Mechanical Properties: The ground truth was established through physical measurements and engineering tests to compare the coated catheters to their non-coated predicate devices.

8. Sample Size for the Training Set

This device does not involve a "training set" in the context of machine learning or AI models. Therefore, this question is not applicable. The performance data is derived from direct testing of the physical device or references to clinical studies, not from a model trained on data.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this physical medical device, this question is not applicable.

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Spire Biomedical Inc.'s Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic Hemodialysis and apheresis. It is a radiopaque polyurethane catheter with a heparin coating, designed for percutaneous insertion or insertion via a cutdown.

The ability of the Carmeda® End-Point Bonded heparin coating to reduce clotting is supported by in-vitro and animal testing.

The catheters are offered in 24cm, 28cm, 32cm, 36cm, 40cm and 55cm lengths.

Catheters longer than 40cm are intended for femoral vein insertion.

Spire Biomedical, Inc.'s 15.5Fr Decathlon Coated catheters are processed with a proprietary Carmeda® BioActive Surface (CBAS®) coating technology that attaches a functionally active heparin to the surfaces of the device. The coating counteracts thrombus from forming on the catheter. Spire's 15.5Fr Decathlon Coated catheters are fully coated with CBAS® on the internal surface and on external surface of the catheter body (from 2cm distal to the cuff to the ends of the distal tips; the cuff is not coated).

The coating is essentially non-leaching. Additionally, maximum amount of heparin on the surface is only 1mg. Therefore, even the effect on a patient's coagulation status would be totally insignificant.

Acceptance Criteria and Study for 15.5Fr Decathlon Coated Catheters (K060155)

The provided documentation describes the acceptance criteria and supporting studies for the 15.5Fr Decathlon Coated Catheters, which incorporate a Carmeda® BioActive Surface (CBAS®) coating to reduce thrombus formation.

The "device performance" in this context refers to the coating's ability to maintain bioactivity and reduce thrombus. The acceptance criteria are implicitly derived from the product claims and the results of the performed in-vitro and animal studies.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • In-vitro Thromboresistance Study: Not explicitly stated, but implies multiple coated and uncoated catheters were tested as part of the "circulation of bovine blood through an outer loop."
  • Animal (Ovine) Studies: 3 animals were used for evaluation. Within each animal, one coated and one uncoated catheter were evaluated.
  • 90-day Durability Tests: Not explicitly stated how many catheters were tested, but "coated catheters" were used.
• Data Provenance: The studies were conducted by Spire Biomedical, Inc. (submitter). The country of origin for the studies is not explicitly stated but is implied to be in the USA where the company is located. The studies are prospective in nature as they are specifically designed to test the performance of the new coated catheter.

3. Number of Experts and Qualifications for Ground Truth

• No information provided regarding the number or qualifications of experts involved in establishing ground truth for the provided studies.
  • For the animal studies, examination "using optical and scanning electron microscopy" would likely involve trained histologists or pathologists, but their specific qualifications are not detailed.
  • Visual evaluations in the in-vitro study and interpretation of mechanical/biological data would also involve expert judgment, but again, details are absent.

4. Adjudication Method for the Test Set

• No information provided regarding a specific adjudication method (e.g., 2+1, 3+1). The studies appear to be quantitative (e.g., radiolabeled measurements, thrombus weight) and qualitative (visual evaluation, microscopy) assessments. Expert consensus or arbitration related to the interpretation of results is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was performed. The described studies are focused on the device's inherent biological and physical performance attributes, not on human reader performance with or without AI assistance. The device is a physical catheter, not an AI-powered diagnostic tool.

6. Standalone Performance Study

• Yes, standalone performance studies were done. All described studies (in-vitro, animal, durability, biocompatibility, mechanical properties) evaluate the performance of the catheter itself, without human intervention as part of the primary performance metric. The "algorithm" in this context is the CBAS® coating technology applied to the catheter, and its performance is evaluated directly.

7. Type of Ground Truth Used

• Experimental/Objective Measurements:
  • In-vitro Thrombus Reduction: Radiolabeled measurements (objective quantitative data) and visual evaluation (qualitative observation).
  • In-vivo Thrombus Reduction (Animal Study): Thrombus weight measurements (objective quantitative data), optical microscopy, and scanning electron microscopy (qualitative and semi-quantitative analysis).
  • Coating Durability: Surface-bound heparin bioactivity (pmol/cm2) measurements over time (objective quantitative data).
  • Biocompatibility: Conformance to ISO 10993 requirements.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical device (catheter) with a bioactive coating, not a machine learning or AI algorithm that requires a "training set" in the traditional sense. The coating technology itself is the "algorithm" and its performance is characterized through direct experimentation.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As explained in point 8, there is no "training set" for this device. The ground truth for the device's performance claims is established through the specific experimental methodologies and measurements described in the in-vitro and animal studies.

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The 55cm 15.5Fr Decathlon™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown. Catheters longer than 40cm are intended for femoral vein insertion.

55cm 15.5Fr Decathlon™ carbothane Twin Lumen Chronic Hemodialysis Catheter with Separated Tips.

The provided text describes a 510(k) summary for the Spire Biomedical 55cm 15.5Fr Decathlon Twin Lumen Chronic Hemodialysis Catheter. This document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. As such, it focuses on demonstrating equivalence rather than establishing new acceptance criteria or conducting a comprehensive study to "prove" performance in the way a clinical trial would for a novel device.

The study referenced is a set of engineering and physical tests to show the device's characteristics are similar to predicate devices or meet established standards.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a dedicated table style, nor does it provide specific numerical performance data against those criteria. Instead, it makes a general statement of compliance.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size for the mechanical and physical tests performed. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective). These details are typically part of internal design control documentation and test reports, not generally included in a 510(k) summary at this level of detail.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This information pertains to studies involving expert review for determining ground truth (e.g., image interpretation). The reported study is a series of mechanical and physical tests on a medical device, which would involve engineering and laboratory testing against established specifications or standards, not expert adjudication of clinical data.

4. Adjudication Method

Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or experts in clinical studies or data labeling. The reported study involves laboratory testing of physical device properties.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study is not mentioned or implied. This type of study assesses the performance of human readers, typically with and without AI assistance, on diagnostic tasks over multiple cases. The provided text is about the substantial equivalence of a physical medical device (catheter) through mechanical and physical testing.

6. Standalone (Algorithm Only) Performance

Not Applicable. A standalone performance evaluation is relevant for AI algorithms. This submission is for a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance data in this context would be:

• Engineering specifications for mechanical and physical properties.
• Established ISO standards for hemodialysis catheters.
• The performance characteristics of the legally marketed predicate devices (Spire Biomedical, Inc. 15.5Fr Decathlon Twin Lumen Chronic Hemodialysis Catheter with Separated Tips "K032061").

8. Sample Size for the Training Set

Not Applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The study involves testing a physical product.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set, there is no ground truth for a training set to establish.

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The 15.5Fr. Decathlon Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.

The 15.5Fr "Decathlon" Twin Lumen Chronic Hemodialysis Catheter is a product line extension of Spire Biomedical, Inc.'s Pourchez XpressO™ flexible radiopaque silicone catheters and supplements our Pourchez XpressO catheter line by offering a polyurethane catheter with similar tip-to-hub length catheters of 24cm, 28cm, 32cm, 36cm & 40cm. The 15.5Fr "Decathlon" Twin Lumen Chronic Hemodialysis Catheter's split tip design (with the exception of the polyurethane catheter body, clear urethane tubing, urethane hub and cross-sectional profile) are identical to our silicone Pourchez XpressO™ catheters listed within our 510(K) Premarket Notification Submission (K013160). The round outer profile with semi-circular cross-sectional lumens is similar to the MedComp Ash Split Cath™. The polyurethane catheter body material is identical to that used in the Kendall Healthcare Maxid™ catheter, as verified by an IR Scan analysis (Appendix (Appendix (G). Optional use of polyvinyl chloride luer adapters has also been qualified.

The provided document (K032061) describes a 510(k) premarket notification for a medical device, specifically a 15.5Fr Polyurethane "Decathlon" Twin Lumen Chronic Hemodialysis Catheter. The document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study that establishes acceptance criteria and then proves the device meets those criteria in the context of an AI/human performance study.

Therefore, much of the requested information regarding AI device performance, sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment cannot be found in this document because the document describes a traditional medical device (a catheter) and not an AI/ML-driven device.

However, I can extract the information related to the device's performance based on the provided text.

Here's an attempt to answer the questions based only on the provided text, noting where information is unavailable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by comparison to predicate devices and/or conformance to established ISO standards for hemodialysis catheters. The document states the device met these criteria. Specific numerical values for criteria are not detailed in this summary.

2. Sample size used for the test set and the data provenance

This document describes a physical medical device (catheter), not an AI algorithm. Therefore, the concept of a "test set" in the context of AI performance data (e.g., images for classification, clinical data for prediction) does not apply here. The document describes tests performed on the physical catheter rather than a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is for a physical medical device, not an AI algorithm requiring expert ground truth for a test set.

4. Adjudication method for the test set

Not applicable. This is for a physical medical device, not an AI algorithm with a test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document pertains to a physical medical device. It does not involve AI or human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This document pertains to a physical medical device, not an AI algorithm.

7. The type of ground truth used

For the performance data described, the "ground truth" is established through:

• Comparison to predicate devices: Performance characteristics (flow rates, priming volumes) were deemed acceptable if they were "similar" to the legally marketed predicate devices.
• Conformance to established ISO standards: Mechanical and physical tests were evaluated against relevant ISO standards for hemodialysis catheters.
• Analytical verification: Material composition was verified through an "IR Scan analysis."

8. The sample size for the training set

Not applicable. This document is for a physical medical device, not an AI algorithm with a training set.

9. How the ground truth for the training set was established

Not applicable. This document is for a physical medical device, not an AI algorithm.

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Pourchez RetrO™ Repair Kit is designed to replace worn or damaged extension connector adapters on Spire Biomedical, Inc.'s Pourchez RetrO catheters.

Pourchez RetrO™ Repair Kit is designed to replace worn or damaged extension connector adapters on Spire Biomedical, Inc.'s Pourchez RetrO Twin Lumen Silicone Hemodialysis Catheters with Separated Tips.

Here's an analysis of the provided text regarding the Pourchez RetrO Repair Kit, focusing on acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size used for the tensile tests. It only states "A series of tensile tests were performed."
The data provenance (country of origin, retrospective/prospective) is not mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The study involves tensile strength testing against an ISO standard, not expert review of medical images or conditions.

4. Adjudication Method for the Test Set

Not applicable, as it is a physical device performance test against a standard, not a subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This type of study is not applicable to
a physical device performance test.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The ground truth used is the minimum tensile strength required by ISO 10555-1. This is a recognized international standard for sterile intravascular catheters.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

Summary of the Study and Device Performance:

The Spire Biomedical, Inc. Pourchez RetrO Repair Kit was evaluated through a series of tensile tests. The acceptance criteria for the device's performance was its ability to meet or exceed the minimum tensile strength specified by the ISO 10555-1 standard for hemodialysis catheters. The study concluded that the repair kit's extension adapters successfully "exceed the minimum tensile strength required by ISO 10555-1," demonstrating its substantial equivalence or conformity to established standards. The exact number of units tested (sample size) for these tensile tests is not detailed in the provided K510 summary.

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Percutaneous insertion kit designed to provide physicians with a dual wire technique for use with Spire Biomedical, Inc.'s Pourchez XpressO™ and Pourchez RetrO™ catheters only.

The "SafeTrac Dual Wire Insertion Kit" provides an alternative method for chronic hemodialysis catheter placement by using an over the wire technique dilating and inserting either the Pourchez RetrO and XpressO catheters over a guidewire percutaneously. The introducers consist of a plastic hub attached to a plastic cannula. The distal end of the cannula is thermally tapered to assist dilation. The hub proximal end has a female luer lock configuration. An optional hub collar may be used to attach the dilator to the catheter. The kits come with two quidewires, two 5F dilators, a 6F, 14F and 16F sheath/dilators in five different lengths. Each kit consists are to be supplied sterile and for single use only. The kits are to be sold in boxes of five.

The provided document does not describe an acceptance criteria or a study that proves the device meets specific acceptance criteria.

Instead, the document is a 510(k) premarket notification summary for a medical device called the "SafeTrac Dual Wire Insertion Kit." The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not to prove performance against specific acceptance criteria through a performance study.

Here's why the requested information cannot be extracted from this document:

• No Acceptance Criteria or Performance Data: The document explicitly states under the "Performance Data" section: "There are no performance criteria for the devices to be included with Spire Biomedical, Inc.'s SafeTrac Dual Wire Insertion Kit." This means no specific performance metrics (like accuracy, sensitivity, specificity, etc.) were established or tested against.
• Substantial Equivalence, Not Performance Study: The entire submission is focused on demonstrating that the SafeTrac Dual Wire Insertion Kit is "substantially equivalent" to existing, legally marketed devices (predicate devices). This typically involves comparing design, materials, intended use, and technological characteristics, rather than conducting a new performance study with clinical endpoints.
• No "Device Performance" Reported: Since no performance study was conducted or acceptance criteria defined, there is no "reported device performance" to tabulate.
• No "Test Set," "Training Set," or "Ground Truth": These concepts are relevant for studies that involve data analysis, machine learning algorithms, or diagnostic performance evaluation, which are not applicable to this 510(k) submission for an insertion kit.
• No "Experts" for Ground Truth or Adjudication: As there's no data-driven study, there's no need for experts to establish ground truth or for adjudication methods.
• No "MRMC Comparative Effectiveness Study" or "Standalone Performance": These types of studies are for evaluating the effectiveness or diagnostic accuracy of a device, which is not the scope of this particular submission.

In summary, the provided document focuses on regulatory clearance through substantial equivalence, not on a detailed performance study with acceptance criteria.

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